Statistical analyses The primary analyses will be conducted on an intention-to-treat basis using data for all randomized participants, although a per protocol analysis of the primary outcome will also be reported. There will be adjusted on the center. Continuous variables will be described with mean (and standard deviation) or median (and range), and categorical variables with number and percentage, as appropriate. The Chi-square or Fisher exact tests will be used for analysis of qualitative variables and the Student t or Mann-Whitney tests for quantitative variables.